21st Century Cures Act
Sponsored By: Representative Rep. Upton, Fred [R-MI-6]
Unknown
Summary
21st Century Cures Act This bill amends the Public Health Service Act to reauthorize the National Institutes of Health (NIH) through FY2018. The NIH Innovation Fund is established to fund a strategic plan, early stage investigators, and high-risk, high-reward research. The NIH may require scientific data to be shared if the research is fully funded by the NIH. The NIH and the Food and Drug Administration (FDA) must implement a system that allows further research on clinical trial data. The Centers for Disease Control and Prevention must expand surveillance of neurological diseases. The Council for 21st Century Cures is established to accelerate the discovery, development, and delivery of innovative cures, treatments, and preventive measures. The Department of Health and Human Services must monitor the use of antibacterial and antifungal drugs and resistance to these drugs. Requirements are established for interoperability and certification of health information technology. Practices that discourage the exchange of electronic health information are prohibited. This bill amends the Federal Food, Drug, and Cosmetic Act to revise the drug approval process, including by: (1) allowing patient experience data to be considered in the risk-benefit assessment of a new drug, (2) requiring the FDA to qualify drug development tools, (3) allowing the FDA to rely upon data previously submitted for a different purpose to expedite the development of certain drugs, and (4) establishing a streamlined data review program for approval of a drug for an additional indication. Manufacturers and distributors of investigational drugs for serious conditions must publish their policies on compassionate use requests. The marketing exclusivity period is extended by six months for a drug approved for a new indication that is a rare disease or condition. The priority review voucher program for rare pediatric diseases is revised and extended. The FDA must: (1) establish a program for priority review of breakthrough medical devices, (2) identify types of devices that do not require a report preceding introduction, and (3) rely on a third-party to determine the safety and effectiveness of changes to medical devices. Regarding medical devices, this bill defines “valid scientific evidence” and makes changes to classification panels and the humanitarian device exemption. “Health software” is defined and, with certain exceptions, exempted from FDA regulations. This bill amends title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services (CMS) to: (1) increase certain payments for new antimicrobial drugs, (2) establish a payment methodology for certain medical devices, and (3) publish online estimated payments for certain outpatient items and services. A pharmaceutical and technology ombudsman within the CMS must respond to complaints from manufacturers of medical products. Medicare prescription drug plan sponsors may limit the access of certain beneficiaries to frequently abused drugs. This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.
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Bill Overview
No Economic Impacts Identified for this Bill
Sponsors & CoSponsors
Sponsor
Rep. Upton, Fred [R-MI-6]
MI • R
Cosponsors
Kevin Cramer
ND • R
Sponsored 5/22/2015
Rep. Bucshon, Larry [R-IN-8]
IN • R
Sponsored 5/22/2015
Bilirakis
FL • R
Sponsored 5/22/2015
Marsha Blackburn
TN • R
Sponsored 5/22/2015
Rep. Brooks, Susan W. [R-IN-5]
IN • R
Sponsored 5/22/2015
Rep. Burgess, Michael C. [R-TX-26]
TX • R
Sponsored 5/22/2015
Rep. Ellmers, Renee L. [R-NC-2]
NC • R
Sponsored 5/22/2015
Griffith
VA • R
Sponsored 5/22/2015
Guthrie
KY • R
Sponsored 5/22/2015
Rep. Lance, Leonard [R-NJ-7]
NJ • R
Sponsored 5/22/2015
Rep. McKinley, David B. [R-WV-1]
WV • R
Sponsored 5/22/2015
Rep. McMorris Rodgers, Cathy [R-WA-5]
WA • R
Sponsored 5/22/2015
Markwayne Mullin
OK • R
Sponsored 5/22/2015
Rep. Murphy, Tim [R-PA-18]
PA • R
Sponsored 5/22/2015
Rep. Shimkus, John [R-IL-15]
IL • R
Sponsored 5/22/2015
Rep. Walden, Greg [R-OR-2]
OR • R
Sponsored 5/22/2015
Rep. Whitfield, Ed [R-KY-1]
KY • R
Sponsored 5/22/2015
Rep. Roskam, Peter J. [R-IL-6]
IL • R
Sponsored 5/22/2015
Rep. Hanna, Richard L. [R-NY-22]
NY • R
Sponsored 5/22/2015
McCaul
TX • R
Sponsored 5/22/2015
Rep. Comstock, Barbara [R-VA-10]
VA • R
Sponsored 5/22/2015
Harris (MD)
MD • R
Sponsored 5/22/2015
Rep. Marchant, Kenny [R-TX-24]
TX • R
Sponsored 5/22/2015
Rep. Yarmuth, John A. [D-KY-3]
KY • D
Sponsored 5/22/2015
Castor (FL)
FL • D
Sponsored 5/22/2015
Rep. Loebsack, David [D-IA-2]
IA • D
Sponsored 5/22/2015
Schakowsky
IL • D
Sponsored 5/22/2015
Tonko
NY • D
Sponsored 5/22/2015
Moore (WI)
WI • D
Sponsored 5/22/2015
Veasey
TX • D
Sponsored 5/22/2015
Dingell
MI • D
Sponsored 5/22/2015
Rep. Fattah, Chaka [D-PA-2]
PA • D
Sponsored 5/22/2015
Rep. Schrader, Kurt [D-OR-5]
OR • D
Sponsored 5/22/2015
Rep. Nolan, Richard M. [D-MN-8]
MN • D
Sponsored 5/22/2015
Rep. Eshoo, Anna G. [D-CA-18]
CA • D
Sponsored 5/22/2015
Peter Welch
VT • D
Sponsored 5/22/2015
Scott, David
GA • D
Sponsored 5/22/2015
Rep. Perlmutter, Ed [D-CO-7]
CO • D
Sponsored 5/22/2015
Courtney
CT • D
Sponsored 5/22/2015
Cohen
TN • D
Sponsored 5/22/2015
DeSaulnier
CA • D
Sponsored 5/22/2015
Rep. Long, Billy [R-MO-7]
MO • R
Sponsored 5/22/2015
Rep. Butterfield, G. K. [D-NC-1]
NC • D
Sponsored 5/22/2015
Clarke (NY)
NY • D
Sponsored 5/22/2015
Rep. Doyle, Michael F. [D-PA-14]
PA • D
Sponsored 5/22/2015
DeGette
CO • D
Sponsored 5/19/2015
Rep. Pitts, Joseph R. [R-PA-16]
PA • R
Sponsored 5/19/2015
Pallone
NJ • D
Sponsored 5/19/2015
Rep. Green, Gene [D-TX-29]
TX • D
Sponsored 5/19/2015
Rep. Barton, Joe [R-TX-6]
TX • R
Sponsored 5/22/2015
Joyce (OH)
OH • R
Sponsored 6/17/2015
Valadao
CA • R
Sponsored 6/17/2015
Rep. Ashford, Brad [D-NE-2]
NE • D
Sponsored 6/17/2015
Nadler
NY • D
Sponsored 6/18/2015
Wasserman Schultz
FL • D
Sponsored 6/18/2015
Rep. Trott, David A. [R-MI-11]
MI • R
Sponsored 6/18/2015
Kaptur
OH • D
Sponsored 6/18/2015
Kelly (IL)
IL • D
Sponsored 6/18/2015
Rep. Rangel, Charles B. [D-NY-13]
NY • D
Sponsored 6/18/2015
Rep. Fudge, Marcia L. [D-OH-11]
OH • D
Sponsored 6/18/2015
McGovern
MA • D
Sponsored 6/18/2015
Rep. Reed, Tom [R-NY-23]
NY • R
Sponsored 6/18/2015
Huizenga
MI • R
Sponsored 6/18/2015
Rep. Rush, Bobby L. [D-IL-1]
IL • D
Sponsored 5/22/2015
Rep. Engel, Eliot L. [D-NY-16]
NY • D
Sponsored 5/22/2015
Rep. McNerney, Jerry [D-CA-9]
CA • D
Sponsored 5/22/2015
Matsui
CA • D
Sponsored 5/22/2015
Rep. Flores, Bill [R-TX-17]
TX • R
Sponsored 6/1/2015
Rep. Johnson, Bill [R-OH-6]
OH • R
Sponsored 6/1/2015
Rep. Gibson, Christopher P. [R-NY-19]
NY • R
Sponsored 6/1/2015
Rep. Kennedy, Joseph P., III [D-MA-4]
MA • D
Sponsored 6/1/2015
Sen. Luján, Ben Ray [D-NM]
NM • D
Sponsored 6/1/2015
Rep. Walz, Timothy J. [D-MN-1]
MN • D
Sponsored 6/1/2015
Castro (TX)
TX • D
Sponsored 6/1/2015
Rep. Bustos, Cheri [D-IL-17]
IL • D
Sponsored 6/1/2015
Frankel, Lois
FL • D
Sponsored 6/1/2015
Brownley
CA • D
Sponsored 6/1/2015
Costa
CA • D
Sponsored 6/1/2015
Wagner
MO • R
Sponsored 6/1/2015
Rep. Davis, Rodney [R-IL-13]
IL • R
Sponsored 6/1/2015
Scalise
LA • R
Sponsored 6/2/2015
Latta
OH • R
Sponsored 6/2/2015
Rep. Harper, Gregg [R-MS-3]
MS • R
Sponsored 6/2/2015
Rep. Olson, Pete [R-TX-22]
TX • R
Sponsored 6/2/2015
Rep. Kinzinger, Adam [R-IL-16]
IL • R
Sponsored 6/2/2015
Rep. Pompeo, Mike [R-KS-4]
KS • R
Sponsored 6/2/2015
Rep. Collins, Chris [R-NY-27]
NY • R
Sponsored 6/2/2015
Rep. Walters, Mimi [R-CA-45]
CA • R
Sponsored 6/2/2015
Allen
GA • R
Sponsored 6/2/2015
Rep. Sarbanes, John P. [D-MD-3]
MD • D
Sponsored 6/2/2015
Rep. Lee, Barbara [D-CA-13]
CA • D
Sponsored 6/2/2015
Rep. Miller, Candice S. [R-MI-10]
MI • R
Sponsored 6/3/2015
Rep. Higgins, Brian [D-NY-26]
NY • D
Sponsored 6/3/2015
Huffman
CA • D
Sponsored 6/3/2015
Rep. Kildee, Daniel T. [D-MI-5]
MI • D
Sponsored 6/3/2015
Quigley
IL • D
Sponsored 6/3/2015
Rep. Takai, Mark [D-HI-1]
HI • D
Sponsored 6/3/2015
Rep. Heck, Joseph J. [R-NV-3]
NV • R
Sponsored 6/3/2015
Resident Commissioner Pierluisi, Pedro R. [D-PR-At Large]
PR • D
Sponsored 6/3/2015
Rep. Benishek, Dan [R-MI-1]
MI • R
Sponsored 6/4/2015
Rep. Walorski, Jackie [R-IN-2]
IN • R
Sponsored 6/9/2015
Rep. Israel, Steve [D-NY-3]
NY • D
Sponsored 6/9/2015
Rep. Hultgren, Randy [R-IL-14]
IL • R
Sponsored 6/9/2015
Rep. Kuster, Ann M. [D-NH-2]
NH • D
Sponsored 6/9/2015
Rep. Yoder, Kevin [R-KS-3]
KS • R
Sponsored 6/9/2015
Rep. Dent, Charles W. [R-PA-15]
PA • R
Sponsored 6/9/2015
Rep. Curbelo, Carlos [R-FL-26]
FL • R
Sponsored 6/9/2015
Rep. Kirkpatrick, Ann [D-AZ-1]
AZ • D
Sponsored 6/9/2015
Rep. Polis, Jared [D-CO-2]
CO • D
Sponsored 6/9/2015
Rep. O'Rourke, Beto [D-TX-16]
TX • D
Sponsored 6/9/2015
Hudson
NC • R
Sponsored 6/9/2015
Rep. Cárdenas, Tony [D-CA-29]
CA • D
Sponsored 6/9/2015
Rep. Capps, Lois [D-CA-24]
CA • D
Sponsored 6/9/2015
Rep. Roe, David P. [R-TN-1]
TN • R
Sponsored 6/9/2015
Rep. Bishop, Mike [R-MI-8]
MI • R
Sponsored 6/9/2015
Rep. Ross, Dennis A. [R-FL-15]
FL • R
Sponsored 6/9/2015
Rep. Payne, Donald M., Jr. [D-NJ-10]
NJ • D
Sponsored 6/9/2015
Del. Norton, Eleanor Holmes [D-DC-At Large]
DC • D
Sponsored 6/11/2015
Rep. Dold, Robert J. [R-IL-10]
IL • R
Sponsored 6/11/2015
Turner (OH)
OH • R
Sponsored 6/11/2015
Rep. Coffman, Mike [R-CO-6]
CO • R
Sponsored 6/11/2015
Rep. Sires, Albio [D-NJ-8]
NJ • D
Sponsored 6/11/2015
Rep. Meadows, Mark [R-NC-11]
NC • R
Sponsored 6/11/2015
Rep. Costello, Ryan A. [R-PA-6]
PA • R
Sponsored 6/11/2015
Rep. Gutierrez, Luis V. [D-IL-4]
IL • D
Sponsored 6/11/2015
Rep. Messer, Luke [R-IN-6]
IN • R
Sponsored 6/11/2015
Walberg
MI • R
Sponsored 6/11/2015
Rep. Salmon, Matt [R-AZ-5]
AZ • R
Sponsored 6/11/2015
Rep. Jenkins, Evan H. [R-WV-3]
WV • R
Sponsored 6/11/2015
Pocan
WI • D
Sponsored 6/11/2015
Peters
CA • D
Sponsored 6/11/2015
Torres (CA)
CA • D
Sponsored 6/15/2015
Lofgren
CA • D
Sponsored 6/15/2015
Meng
NY • D
Sponsored 6/15/2015
Takano
CA • D
Sponsored 6/15/2015
Rep. Pittenger, Robert [R-NC-9]
NC • R
Sponsored 6/15/2015
Rep. Denham, Jeff [R-CA-10]
CA • R
Sponsored 6/15/2015
Rep. Barletta, Lou [R-PA-11]
PA • R
Sponsored 6/15/2015
Rep. Hardy, Cresent [R-NV-4]
NV • R
Sponsored 6/15/2015
Rep. Ruppersberger, C. A. Dutch [D-MD-2]
MD • D
Sponsored 6/15/2015
Vargas
CA • D
Sponsored 6/15/2015
Garamendi
CA • D
Sponsored 6/15/2015
Rep. Heck, Denny [D-WA-10]
WA • D
Sponsored 6/15/2015
Bera
CA • D
Sponsored 6/15/2015
Rep. Luetkemeyer, Blaine [R-MO-3]
MO • R
Sponsored 6/16/2015
Rep. Zeldin, Lee M. [R-NY-1]
NY • R
Sponsored 6/16/2015
Clark (MA)
MA • D
Sponsored 6/16/2015
Bost
IL • R
Sponsored 6/16/2015
Rep. Lawrence, Brenda L. [D-MI-14]
MI • D
Sponsored 6/16/2015
Velazquez
NY • D
Sponsored 6/16/2015
Rogers (AL)
AL • R
Sponsored 6/16/2015
Rep. Edwards, Donna F. [D-MD-4]
MD • D
Sponsored 6/17/2015
Rep. Young, David [R-IA-3]
IA • R
Sponsored 6/17/2015
Rep. Katko, John [R-NY-24]
NY • R
Sponsored 6/17/2015
Moulton
MA • D
Sponsored 6/17/2015
Rep. Fortenberry, Jeff [R-NE-1]
NE • R
Sponsored 6/17/2015
Rep. McHenry, Patrick T. [R-NC-10]
NC • R
Sponsored 6/17/2015
Rep. Hinojosa, Ruben [D-TX-15]
TX • D
Sponsored 6/17/2015
Rep. Cartwright, Matt [D-PA-17]
PA • D
Sponsored 6/17/2015
Moolenaar
MI • R
Sponsored 6/18/2015
Rep. Donovan, Daniel M., Jr. [R-NY-11]
NY • R
Sponsored 6/18/2015
Rep. Wenstrup, Brad R. [R-OH-2]
OH • R
Sponsored 6/18/2015
Rep. Ellison, Keith [D-MN-5]
MN • D
Sponsored 6/18/2015
Rep. Hastings, Alcee L. [D-FL-20]
FL • D
Sponsored 6/18/2015
Rep. Maloney, Carolyn B. [D-NY-12]
NY • D
Sponsored 6/18/2015
LaMalfa
CA • R
Sponsored 6/18/2015
Rep. Crenshaw, Ander [R-FL-4]
FL • R
Sponsored 6/18/2015
Rep. Sinema, Kyrsten [D-AZ-9]
AZ • D
Sponsored 6/18/2015
McCollum
MN • D
Sponsored 6/18/2015
Webster (FL)
FL • R
Sponsored 6/18/2015
Del. Bordallo, Madeleine Z. [D-GU-At Large]
GU • D
Sponsored 6/18/2015
Rep. Gibbs, Bob [R-OH-7]
OH • R
Sponsored 6/23/2015
Boyle (PA)
PA • D
Sponsored 6/23/2015
Rep. Conaway, K. Michael [R-TX-11]
TX • R
Sponsored 6/23/2015
Rep. Knight, Stephen [R-CA-25]
CA • R
Sponsored 6/23/2015
Womack
AR • R
Sponsored 6/23/2015
DesJarlais
TN • R
Sponsored 6/23/2015
Rep. Royce, Edward R. [R-CA-39]
CA • R
Sponsored 6/23/2015
Diaz-Balart
FL • R
Sponsored 6/23/2015
Stefanik
NY • R
Sponsored 6/23/2015
Zinke
MT • R
Sponsored 6/23/2015
Rep. Capuano, Michael E. [D-MA-7]
MA • D
Sponsored 6/23/2015
Rep. Jackson Lee, Sheila [D-TX-18]
TX • D
Sponsored 6/23/2015
Rep. Tiberi, Patrick J. [R-OH-12]
OH • R
Sponsored 6/23/2015
Rep. Herrera Beutler, Jaime [R-WA-3]
WA • R
Sponsored 6/23/2015
Chris Van Hollen
MD • D
Sponsored 6/23/2015
Rep. Guinta, Frank C. [R-NH-1]
NH • R
Sponsored 6/23/2015
Rep. Ros-Lehtinen, Ileana [R-FL-27]
FL • R
Sponsored 6/23/2015
Simpson
ID • R
Sponsored 6/23/2015
Bonamici
OR • D
Sponsored 6/24/2015
Rep. Cicilline, David N. [D-RI-1]
RI • D
Sponsored 6/24/2015
Rep. Lipinski, Daniel [D-IL-3]
IL • D
Sponsored 6/24/2015
Rep. Rice, Kathleen M. [D-NY-4]
NY • D
Sponsored 6/24/2015
Rep. Paulsen, Erik [R-MN-3]
MN • R
Sponsored 6/24/2015
Rep. Speier, Jackie [D-CA-14]
CA • D
Sponsored 6/24/2015
Rep. Cook, Paul [R-CA-8]
CA • R
Sponsored 6/24/2015
Rep. Langevin, James R. [D-RI-2]
RI • D
Sponsored 6/24/2015
Rep. Stivers, Steve [R-OH-15]
OH • R
Sponsored 6/24/2015
Cleaver
MO • D
Sponsored 6/24/2015
Rep. Collins, Doug [R-GA-9]
GA • R
Sponsored 6/24/2015
Rep. Hunter, Duncan D. [R-CA-50]
CA • R
Sponsored 6/24/2015
Rep. Hahn, Janice [D-CA-44]
CA • D
Sponsored 6/24/2015
Rep. Rigell, E. Scott [R-VA-2]
VA • R
Sponsored 6/24/2015
Rep. Chabot, Steve [R-OH-1]
OH • R
Sponsored 6/24/2015
DelBene
WA • D
Sponsored 6/24/2015
Rep. LoBiondo, Frank A. [R-NJ-2]
NJ • R
Sponsored 6/24/2015
Rep. Roybal-Allard, Lucille [D-CA-40]
CA • D
Sponsored 6/25/2015
Perry
PA • R
Sponsored 6/25/2015
Rep. Delaney, John K. [D-MD-6]
MD • D
Sponsored 6/25/2015
Rep. Lewis, John [D-GA-5]
GA • D
Sponsored 6/25/2015
Lieu
CA • D
Sponsored 6/25/2015
Johnson (GA)
GA • D
Sponsored 6/25/2015
Wilson (FL)
FL • D
Sponsored 6/25/2015
Keating
MA • D
Sponsored 6/25/2015
Rep. Brown, Corrine [D-FL-5]
FL • D
Sponsored 6/25/2015
Rep. Kind, Ron [D-WI-3]
WI • D
Sponsored 6/25/2015
Rep. Marino, Tom [R-PA-10]
PA • R
Sponsored 6/25/2015
Rep. Brady, Robert A. [D-PA-1]
PA • D
Sponsored 6/25/2015
Rep. Farr, Sam [D-CA-20]
CA • D
Sponsored 6/25/2015
Calvert
CA • R
Sponsored 6/25/2015
Larson (CT)
CT • D
Sponsored 6/25/2015
Chu
CA • D
Sponsored 6/25/2015
Hoyer
MD • D
Sponsored 6/25/2015
Rep. Johnson, Eddie Bernice [D-TX-30]
TX • D
Sponsored 6/25/2015
Waters
CA • D
Sponsored 6/25/2015
Rep. Lowenthal, Alan S. [D-CA-47]
CA • D
Sponsored 6/25/2015
Rep. Ryan, Tim [D-OH-13]
OH • D
Sponsored 6/25/2015
Rep. Davis, Susan A. [D-CA-53]
CA • D
Sponsored 6/25/2015
Rep. Kilmer, Derek [D-WA-6]
WA • D
Sponsored 6/25/2015
Tammy Duckworth
IL • D
Sponsored 6/25/2015
Roll Call Votes
No roll call votes available for this bill.
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